The following is a description of the typical essential competencies needed to plan, conduct, and report a clinical research program in a regulated environment. Each competency is described, as well as the knowledge and skills a sponsor's representative would need to be successful in completing the task. Judgment can then be applied to the most urgent needs in providing education and training around the knowledge and skills.
While many readers will be thoroughly familiar with the tasks described below and described in more detail throughout the chapters of this book, a brief explanation of the task is provided, together with the success factor in completing the task.
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